A Study to Evaluate ENERGI-F703EB Cream in Epidermolysis Bullosa
Sponsor: Energenesis Biomedical Co., Ltd. • ClinicalTrials.gov ID: NCT07858422
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This is a phase II, intra-subject randomized, double-blind, vehicle-controlled, parallel, multicenter study to evaluate the safety and preliminary efficacy of ENERGI-F703EB Cream in subjects who are ≥ 18 years old with epidermolysis bullosa simplex (EBS), junctional epidermolysis bullosa (JEB), or dystrophic epidermolysis bullosa (DEB). In total, approximately 24 subjects will be enrolled from multiple sites in Taiwan. The study duration per subject is approximately 16 weeks; which includes a 2 to 4-week period between Visit 1 and Visit 2 for screening, an 8-week period from Visit 2 to Visit 7 for treatment, and a 4-week period from Visit 7 to Visit 9 for safety follow-up.
Interventions
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ENERGI-F703EB Cream
(Drug)
Standard of care and ENERGI-F703EB Cream is applied for the treatment of Epidermolysis Bullosa
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Matched vehicle cream
(Drug)
Standard of care and matched vehicle cream is applied for the treatment of Epidermolysis Bullosa
Eligibility criteria
Conditions
Locations
- National Cheng Kung University Hospital — Tainan, Taiwan
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Learn MoreOfficial Source
Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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